notice_of_intent.pdf

PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT) SYNOPSIS

INTRODUCTION

THIS IS A PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT)

SYNOPSIS TO AWARD A CONTRACT OR PURCHASE ORDER WITHOUT

PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME).

The National Heart, Lung, and Blood Institute (NHLBI), Office of Acquisitions (OA) on behalf of the National Institutes of Dental and Craniofacial Research (NIDCR) intends to negotiate and award a purchase order without providing for full and open competition (Including brand-name) to Johns Hopkins University School Medicine Division of Rheumatology, 5000 Eastern Ave, Suite 4000, Baltimore MD for a part time Rheumatologist.

NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE

The intended procurement is classified under NAICS code 541990, All Other Professional, Scientific, and Technical Services, Small Business Size, $15.0 Million.

REGULATORY AUTHORITY

The resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 2021-06 effective date 07-12-2021.

This acquisition is conducted under the procedures as prescribed in FAR subpart 13— Simplified Acquisition Procedures at an amount not exceeding the SAT.

STATUTORY AUTHORITY

This acquisition is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13—Simplified Acquisition Procedures, Subpart 13.106-1 (b) (1), Soliciting from a single source and is not expected to exceed the simplified acquisition threshold.

Contracts awarded using FAR Part 13—Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6—Competition Requirements.

DESCRIPTION OF REQUIREMENT (Include purchase description, technical specifications, evaluation criteria, submission instructions, etc., as prescribed in FAR Subpart 5.207(c))

Background The National Institutes of Health (NIH) is the nation’s medical research agency—making important discoveries that improve health and save lives. The National Institute of

Dental and Craniofacial Research (NIDCR) improves dental, oral, and craniofacial health through research, research training, and the dissemination of health information.

The Dental Clinical Resource Core (DCRC) conducts clinical research, provides training in clinical research through the Clinical Research Fellowship and provides an oral medicine and dental consultation service for the unique Clinical Center patient population. It is the goal of the DCRC to advance the development of clinical applications of laboratory research to benefit both oral and systemic health. The DCRC has a continuing requirement for a part time Rheumatologist.

Purpose and Objectives Through this collaboration, the goal is to advance the clinical management and mechanistic understanding of salivary gland disorders, Sjogren's syndrome and other rheumatologic conditions with manifestations in salivary gland pathology. The NIDCR Salivary Gland Disorders research team is a leader in the field and has a long-standing history of research to this condition. There is a significant amount of patient data and research data that continues to provide important information on the disease and the management of Sjogren's syndrome. The mission of the NIDCR includes research in the area of salivary gland pathologies including conditions such as Sjogren's syndrome and sequelae from therapies that result in sicca complex.

NIDCR will greatly benefit from the clinical and basic research in the form of publications, career development, and teaching collaborations. Research, training the next generation and clinical care are part of the NIDCR mission.

Period of Performance Base Period: 12 Months

Project Description Scope of Work

Contractor Requirements:

o The Contractor shall provide clinical expertise that will enhance the submission of research human subject protocols, amendments, and adverse events reporting to regulatory bodies, including the FDA and Office of Biotechnology Activities by supporting the Salivary Gland Disorders research team.

o The Contractor shall provide clinical expertise and management for patients/subjects with rheumatologic conditions, particularly those associated with abnormal salivary gland pathology. This will typically occur through completion of appropriate case report forms, data entry, and consultation notes.

o The Contractor shall participate in the screening and enrollment of subjects to clinical research protocols related to the Salivary Gland Disorders research team.

o The Contractor shall work in the NIDCR Dental Clinic for at least two days per week in consultation with the Salivary Gland Disorders research team. The Contractor is required to work one day per week on-site and one day per week off-site.

o The Contractor shall participate in various levels of research analysis involving the Salivary Gland Disorders research team and database with the expectation that publications, co-authorship and grant collaborations will occur as a result of this assignment.

Contractor Tasks:

The Contractor shall perform the below tasks for 832 hours over the course of the year and will be evaluated annually on these outcome measures:

Clinical Task o Provide specific expertise in Sjogren's syndrome and rheumatological conditions with oral manifestations, as well as manage and evaluate such patients.

Research Task o Provide clinical research expertise in Sjogren’s syndrome and rheumatological conditions with oral manifestations, and will identify potential research subjects for NIDCR studies. These activities will result in publications, abstract submissions, national and international presentations with NIDCR investigators and clinicians, with acknowledgement of this collaboration.

Training Task o Provide clinical training in Sjogren’s syndrome and rheumatological conditions with oral manifestations to staff, fellows, residents and other trainees as it relates to the Salivary Gland Disorders research team.

Professional Qualifications:

o Demonstrate clinical expertise in medical, rheumatologic, and autoimmune conditions by holding a medical degree, and preferably board certification in rheumatology o Demonstrate clinical activity through an active medical license in the US in good standing o Demonstrate clinical research expertise through extensive publications in the area of Sjogren’s syndrome and rheumatological conditions with oral manifestations o Demonstrate an active collaboration with a dental clinical research team in the area of salivary gland disorders

Government Requirements:

The Dental Clinic and the Office of the Clinical Director shall provide administrative and clinical support to the Contractor and/or the Oral Surgeon.

Administrative Support o The Office of the Clinical Director (OCD) will prepare the credentialing package for the Contractor to work at the NIH Clinical Center provided that all materials are received from the Contractor and are up to date and active. This is a requirement and not an option.

o The OCD will provide the Contractor with access to the NIH Campus, a work station, a telephone, and access to necessary NIH systems to perform duties at the NIH.

Clinical Support o The NIDCR Salivary Gland Disorders research team will provide clinical support, including providing space and supplies in the dental clinic related to the clinical and research projects of the research team.

Evaluation of the Contractor The NIDCR Clinical Director will evaluate the performance of the Contractor. The NIDCR Clinical Director may request reports, performance evaluations from the contractor to access the overall clinical performance of the rheumatologist for credentialing evaluation purposes.

Location of Services National Institutes of Health, NIDCR 10 Center Drive, Building 10 Bethesda, MD 20892

Other Important Considerations None

CONTRACTING WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION

(INCLUDING BRAND-NAME) DETERMINATION

It is being recommended that this requirement is sole-sourced to Johns Hopkins University to maintain the continuity of services. Dr. Alan Baer at the University has collaborated on this project for five years with the Salivary Gland Disorders research team. Dr. Baer is an expert in the field and completely understands the importance of oral health in the Sjogren syndrome. He has a strong relationship with the research team and research subjects. Dr. Baer has referred many Johns Hopkins University patients with effective conditions for enrollment at the NIH. To ensure this continues development in research the NIDCR relies on Dr. Baer, Rheumatologist, and Johns Hopkins patients for it’s continues success.

CLOSING STATEMENT

This synopsis is not a request for competitive proposals. However, interested parties may identify their interest and capability to respond to this notice. Responses to this notice shall contain sufficient information to establish the interested parties’ bona-fide capabilities for fulfilling the requirement and include: unit price, list price, shipping and handling costs, the delivery period after contract award, the prompt payment discount terms, the F.O.B. Point (Destination or Origin), the Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov.”

A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. The information received will normally be considered solely for the purposes of determining whether to proceed on a non-competitive basis or to conduct a competitive procurement.

All responses must be received by 08/13/2021 at 12:00pm EST. Responses must be submitted via the FedConnect webportal (www.fedconnect.net). Potential Offerors do not need to register to view a notice; however, in order to submit questions and/or response to this Notice, an account will need to be established. Should you require a waiver not to use FedConnect, please contact the Contracting Officer listed in this notice.

All responsible sources may submit a capability statement, proposal, or quotation, which shall be considered by the agency.

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